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(Email C.J.Lowe@leeds.ac.uk). Keywords. Chronic therapy. General practice. Medication review. Method. Pharmacist. Abstract. Medication review of patients on ...
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Development of a method for clinical medication review by a pharmacist in general practice • C . J . L o w e , D . R . P e t t y, A . G . Z e r m a n s k y a n d D . K . R a y n o r

Pharm World Sci 2000;22(4): 121-126. © 2000 Kluwer Academic Publishers. Printed in the Netherlands. C.J. Lowe (correspondence), D.R. Petty, A.G. Zermansky and D.K. Raynor : Division of Academic Pharmacy Practice, School of Healthcare Studies, University of Leeds, 10, Clarendon Road, Leeds LS2 9NN, UK, (Email [email protected]) Keywords Chronic therapy General practice Medication review Method Pharmacist Abstract Medication review of patients on long-term treatment in general practice in the UK has been reported to be inadequate. Proposals followed suggesting that pharmacists could use their expertise to lead such a medication review in conjunction with the general practitioner. This paper describes the concept of clinical medication review by a pharmacist based in general practice. We describe the development of a method for a structured and systematic process for undertaking such a review in clinics conducted by a pharmacist. The method was developed for a nationally funded study in the UK. We provide a definition of clinical medication review and suggests a structure for the process through data gathering, evaluation and implementation. Accepted May 2000

Introduction

Developing the method

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Background Pharmacists have pharmacological knowledge and many have acquired consultation skills. While they lack the breadth of pathological knowledge and clinical skills of doctors, these may not be necessary to provide what would, in effect, be a screening service to patients on apparently stable drug regimens. This is reflected in reports by the UK Audit Commission and Royal College of Physicians which have suggested that a pharmacist may be able to help initiate a review of repeat prescribing [11,12]. The Primary Care White Papers also propose new roles in the prescribing or supply of medicine, including medication review by a pharmacist [13,14]. Although a number of service developments have been started by health authorities which involve pharmacists in reviewing repeat prescribing [15], there are few published controlled trials in the UK. The concept is not new in North America, where trials have demonstrated the benefits of pharmacist involvement in reviewing long term prescribing in the community [16-20]. Borgsdorf et al [18] describe a medication review service at a managed care facility. The service involved a pharmacist reviewing medication in consultation with the patient. During the visit the pharmacist evaluated how the patient used the medication, their clinical response to it and adverse effects experienced. If necessary the pharmacist taught the patient how to use the drugs more appropriately. The pharmacist then changed the medication as appropriate and arranged any follow up visits. In the study 65% of the drugs reviewed each month were judged problematic. Cassidy et al. [17] evaluated the impact of two types of pharmacist medicine review clinic on physician time. In one clinic the pharmacists conducted a chart review only and did not see the patient. In the second clinic the pharmacist also interviewed the patient. A pharmacist reduced practitioner time in both clinics with the greatest impact observed in the interview clinic. Two studies [19,20] used prognostic indicators to target patients who should receive a medication review. One study [16] used the Medical Appropriateness Index (MAI) to assess the appropriateness of the patients’ regularly scheduled medicines. Whilst work has been done in the UK to develop indicators of appropriateness of lone term prescribing [21] their role in evaluating prescribing at patient level is unclear. A number of studies have evaluated the role of the pharmacist in reviewing repeat prescriptions in the UK [22-25]. In the majority of cases the review did not

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Review of patients on chronic therapy treated by general practitioners has been shown to be inadequate [1]. The poor quality of prescription review has been highlighted in two UK studies [1 2], where evidence of inadequate clinical control included patients frequently receiving repeat prescriptions without formal authorisation. There was also an absence of checks on medication adherence and inadequate methods of identifying patients needing a review. The proportion of patients on repeat medication rises with age and 90% of patients who are 85 years old or over receive prescriptions on a repeat basis [3]. The incidence of adverse drug reactions and drug related admissions to hospital also rises with age [4 5]. Inappropriate prescribing in older people is often a contributing factor to hospital admissions [6 7]. In one study 23.7% of inpatients admitted to general and medical beds were receiving contraindicated or adversely interacting drugs [8]. However, if all patients on regular repeat prescriptions were reviewed by the general practitioner every year the additional workload for each doctor would represent approximately an extra weeks work per annum [9]. This is not a practical proposition in the current general practice environment in the UK. One method of addressing this problem is for pharmacists to conduct medication reviews. The UK NHS Health Technology Assessment programme identified this as a priority, and is funding research on Clinical Medication Review by a clinical pharmacist of patients on repeat prescriptions in general practice (the CMR

study) [10]. The nature of such an intervention is a key issue and this paper describes the method for clinical medication review developed for use in the study.

involve the patient [23,24,25]. The pharmacist reviewed the notes and surgery computer and made recommendations to the doctor. The nature of the recommendations varied, some focusing on technical aspects of prescribing, eg. inappropriate qualities [23] and others on appropriateness of therapy [22,24]. Burtonwood [22] reports on a pharmacist-run medicine review clinic which involved interviewing the patient. The purpose of the interview was to elucidate the patients’ medicine taking behaviour and their experience of adverse effects. Origins of method This paper is an extension of work done by the authors [26,27]. We previously described a hospital based self-medication study in which a medicine review was an integral part [26]. The review was initiated by the pharmacist and considered both the patients reported use of medicines as well as the appropriateness of each drug. The role of a pharmacist in medicine review was further developed and applied to general practice [27]. Patients were interviewed at home about their medicine use by the pharmacist who reviewed the medication with the general practitioner. In the current paper we describe a clinical medication review by a pharmacist which takes place in the surgery. We propose that the pharmacist will judge which changes, arising from a review, will need to be referred to the doctor and which they can initiate themselves. Definition Clinical medication review is the process where a health professional reviews the patient, their illness and drug treatment in a consultation. The progress of the conditions being treated and the appropriateness and continuing need of each drug are considered. Other issues, such as medication adherence, actual and potential adverse effects, interactions and the patient’s understanding of the condition and its treatment are also considered where appropriate. It is a 3stage process (see Figure 1).

Assess adherence to medication Patients do not always take their medication as prescribed. This could be altering the dose, frequency or simply stopping the medicine altogether. The reason may be intentional i.e. they have made a conscious decision not to take the medication and there could be a number of reasons for this: • Misunderstanding of the purpose of medication. • Experiencing side effects and deciding to stop. • Perception that medication is ineffective or inappropriate. Alternatively the non-adherence may be unintentional; they may want to take the medicines correctly and not be able to. This may arise from: • inadequate instructions on the label e.g. “as directed”; • lack of knowledge of the purpose of medicine. • packaging difficulties eg. inability to open bottles or read label; • inability to use device e.g. inhaler, eye drops. • complex medicine regime which the patient cannot understand; • memory difficulties e.g. from simple forgetfulness to dementia. Identify unaddressed medical problems The consultation may also highlight previously unknown or unrecognised problems. The pharmacist has a responsibility to ensure that these problems are addressed. Minor problems could be treated by the pharmacist e.g. analgesia for self-limiting conditions. Major problems will need to be discussed with the patient’s doctor. Stage 2 - Evaluation

Setting Patients are invited to the review at the surgery by letter. The pharmacist conducts clinics in the surgery, and during each consultation with the patient, undertakes the process described below.

Consider continuing need The continuing need by the patient for each drug should be evaluated with the doctor. It may be necessary to discontinue, or switch to a more appropriate treatment.

Process

Identify suboptimal treatment of recognised disease There should be evidence of efficacy for each prescribed medicine. Evidence can be found from both the clinical record and the patient. Pharmacists are not qualified to perform a physical examination, or to diagnose, but certain obvious signs and symptoms can be evaluated, e.g. ankle swelling in a patient with heart failure. If there is evidence of suboptimal treatment, it is important to ensure that appropriate tests/investigations are conducted eg. blood sample taken for urea and electrolytes, blood pressure measurement. If the pharmacist is not able to perform the test or make a diagnosis, then referral to an appropriate member of the team is required, e.g. nurse for blood samples, GP for diagnosis. Once results are known, suggestions for medication change should be discussed with the doctor as necessary.

Stage 1 – Data gathering

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Identify drugs taken It is important to establish which medicines the patient is actually taking. This may differ from what is prescribed or recorded in the records. This could be because the patient is not taking the medicine as prescribed or because the records themselves are not up to date. Patients may be taking:• regular non-prescription medicines (e.g. 75mg aspirin); • illegal drugs; • medicines prescribed for other patients (e.g. a relative). 122

Identify indications It is important to attempt to identify the original indication for each drug from the medical record. Where it is not recorded, the patient may know why the drug was originally started.

Figure 1 Medicine review process.

Consider costs Changing therapy to a less expensive but equally efficacious alternative does not directly benefit the patient. It does, however, benefit the population as a whole, since it releases additional resources for the National Health Service. Prior agreement with the practice is required for the types of changes that are acceptable. The range of possible changes are shown in Figure 2. Reasons for making such changes need careful explanation to the patient, who should be given the opportunity to switch back if they are unhappy with the new medicine. The pharmacist should ensure that all appropriate monitoring is done and the new medicine has equal or improved efficacy and tolerability to the previous medicine.

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Identify side effects Side effects may not be apparent from the clinical record. Asking the patient will help to identify clinically relevant side effects of medication. The British National Formulary is a standard against which side effects can be judged. Appropriate action should be implemented and relevant adverse drug reactions reported to the relevant body (in the UK the Committee on Safety of Medicines).

Identify clinically relevant drug interactions or contraindications Where clinically relevant interactions or contraindications are identified, suitable amendments to the therapy should be made.

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Doses may be suboptimal for a number of reasons: • Treatment may be initiated and not titrated to full dose e.g.statins. • Doses may be too high in light of new evidence, e.g. bendrofluazide 5mg or atenolol 100mg for hypertension. • Patient’s condition may have deteriorated or improved. Subsequent patient follow-up will be required to ensure that the response is satisfactory at the new dose.

The pharmacist will need to judge (guided by the agreed protocol) whether the patient needs to be referred to the doctor for a physical examination. In some instances it will be possible for the pharmacist to discuss the case with the doctor and then implement the change: • Identification of clinically significant side effects or drug interactions which require a change to therapy. • Initiation of new therapy eg. aspirin prophylaxis following a myocardial infarction. Figure 2 • Change of existing treatment to a different theraExamples of changing therapy to a less expensive but peutic group. equally effective alternative. • Discontinuation of therapies which have limited clinical value • Exacerbation of an existing medical problem eg. Stage 3 – Implementation heart failure or chronic bronchitis. • Identification of a new medical problem. Categories of intervention The third stage of the pharmacist clinical medication There will be some minor changes to treatment that review involves implementing changes and their doc- the pharmacist can initiate themselves without referumentation. It is important for the general practition- ence to a doctor. Examples of these are: er and the pharmacist to establish a protocol for • Optimising dosage e.g. reducing bendrofluazide implementing changes. This would include changes from 5mg to 2.5mg for hypertension. that can be made without prior consultation with the • Checking cholesterol levels and increasing dose of doctor. For the purposes of the CMR study, 8 broad drug accordingly. categories of pharmacist intervention were defined • Formulation change, eg. to a slow release preand are described in Table 1, along with examples of paration. reasons for each intervention. • Switch from proprietary to generic medication. Again these will be covered by the protocol. Process for implementing change The review may have identified one or more serious Patient education or counselling problems that need the involvement of the doctor. The consultation will identify some patients who • Switch from a branded to generic drug; • Change in formulation, e.g. a powder inhaler to a metered dose inhaler; • Modified release product to a plain drug; • Combination product to the individual components; • Switch within a therapeutic group, e.g. one beta-blocker for another

Table 1 Medication interventions with examples of reasons for the intervention

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Medication intervention

Reason for intervention

Stop drug

Indication no longer valid Duplication of therapy Non adherence Adverse effect

Switch drug (same indication)

Contraindication Adverse effect Drug interaction Cheaper alternative

Adherence counselling (no drug change)

Non-adherence

Alter formulation, dose, timing

Formulation, dose or dosing schedule not optimal

Start drug (new indication)

Addition of drug for untreated indication

Test required

Monitor efficacy Minimise ADRs Monitor adherence

Technical

Generic switch Altering quantities on prescription Deleting unused medication from repeat record Adding dosage instructions

GP referral

Insufficient information to make recommendation Complex medical conditions New diagnosis suspected Worsening of existing conditions requiring a medical assessment

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4 Larmour 1, Dolphin RG, Baxter H, Morrison S, Hooke DH,

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either misunderstand the purpose of their medication how patients manage their medicines in the home setor who are not using it appropriately. Examples of this ting (including medication adherence issues). include: The CMR approach contrasts with previous UK studies involving pharmacists reviewing repeat pre• Patients not taking their steroid inhaler regularly. scribing [23,24,25]. In these studies the role of the • Patients unable to use their medication e.g. open pharmacist focused on the prescribing review, remote bottle tops or use eye drops. from the patient. Clinical medication review, in con• Patients who perceive that the treatment may be trast, is patient-centred and includes aspects such as:harming them or not giving them benefit. • Current clinical situation The pharmacist will need to identify reasons for the • Medication adherence: what the patient is actually patient’s difficulties with the medication and negotaking and how they are taking it tiate a plan to help them use it correctly. This may • Continuing need of medication involve providing them with appropriate information • Patient understanding of medicines or advice. Alternatively it may involve liasing with the • Side effects local pharmacy to alter the packaging to the medication. Clinical medication review could take place in the surgery, a community pharmacy or a patient’s home. Communication and record keeping The advantages of surgery-based consultations are The following steps must be taken to ensure appropri- that the medication records are available, ease of liaiate record keeping and communication: son with the doctors and the pharmacist can conduct a “clinic”. The disadvantage is that it may be difficult • Record details of the medicine review in the notes. for some older patients to travel to the practice and a This includes any proposals, follow-up required and community pharmacy may be more easily accessible outcomes expected. to patients. However, finding room for a private inter• Some interventions will need permission from the view may be difficult. Conducting the review in the doctor before alterations can be made to treatpatients’ home is the most convenient for the patient, ment. This is a professional decision at the but the most time consuming for the pharmacist. pharmacists’ discretion. The approach outlined in this paper adopts a more • Where medication has been changed, the compupatient-centred and less drug-centred approach, in terised repeat medication record must also be which medication is considered in the context of altered. A date for the next medication review overall health. It takes a step forward in recognising should be added to the computer so that reception that the clinical review of medication in general pracstaff knows when next to call in the patient for tice is often inadequate and proposes a structured review. approach that pharmacists could adopt to fulfil this There will be some patients who are well established role. In a recently published UK Department of Health on their treatment, experiencing no problems and do report [28], it is proposed that two new categories of not need any change to be made. The pharmacist will prescribers could be introduced, “independent prestill need to document the current medication and scribers” who are responsible for the initial assessrecord that no intervention was necessary. ment of a patient, devising a treatment plan and authorised to prescribe medicines as part of the plan. Communication with the patient about changes in Also, “dependent prescribers” who are authorised to therapy is important. It may be important to liase prescribe certain medicines within an agreed treatwith the patient’s carers. Ideally the patient should be ment protocol for patients whose conditions have given a written copy of: been diagnosed by an independent prescriber. A • Name of drug pharmacist performing the task of a clinical medica• Strength, dose and frequency tion review, as outlined in this paper, would clearly fall • What it is for into the latter category. • Date of prescribing Finally, it is important to consider training needs. • Review date Most undergraduate courses teach basic clinical and • In what circumstances to see the doctor sooner communication skills. The level of these skills that would be required for a clinical medication review in Discussion primary care are significantly higher. This would This paper describes the development of a method for mean that relevant post graduate training would be a systematic approach to pharmacist review of patient necessary before a pharmacist could take up this role. medication, in the general practice setting. It is based on the hypothesis that a suitably qualified clinical Acknowledgement pharmacist can undertake such a clinical medicine We thank Nick Freemantle and Andy Vail for their review. Pharmacist clinical medication review differs advice on the writing of this paper and Denise from a review undertaken by a GP, because pharmaButtress for secretarial support. cists lack in-depth training in diagnosis and are not currently able to prescribe. However, the pharmacist References can directly manage many elements of the medication 1 Zermansky AG. Who controls repeats? Br J Gen Pract 1996;46:643-7. review process, in collaboration with other members 2 McGavock H, Wilson-Davis K, Connolly JP. Repeat prescribing of the health care team. The pharmacist brings particmanagement – a cause for concern? Br J Gen Pract ular skills to the process, in terms of a knowledge of 1999;49:343-7. 3 Harris CM, Dajda R. The scale of repeat prescribing. Br J Gen applied pharmacology, along with an understanding Pract 1996;46:649-53. of how medicines are supplied and presented and

McGrath BP. A prospective study of hospital admission due to drug reactions. Aust J Hosp Pharm 1991;21(2):90-9. 5 Ives TJ, Bentz EJ, Guryther RE. Drug related admissions to a family medicine inpatient service. Arch Intern Med 1987;147:1117-25. 6 Tully MP, Tallis RC. Inappropriate prescribing and adverse drug reactions in patients admitted to an elderly care unit. J Geriatr Drug Ther 1991;6(1):63-74. 7 Lindley CM, Tully MP, Paramsolty V, Tallis RC. Inappropriate medication is a major cause of adverse drug reactions in elderly patients. Age & Ageing 1992;21:294-300. 8 Gosney M, Tallis R. Prescription of contraindicated & interacting drugs in elderly patients admitted to hospital. Lancet 1984;564-7. 9 Purves I, Kennedy J. The quality of general practice repeat prescribing. Newcastle:University of Newcastle-upon-Tyne, 1994. 10 Annual Report of the NHS Health Technology Assessment Programme 1999. London: Department of Health. 11 Audit Commission. A prescription for improvement. Towards more rational prescribing in general practice. London: HMSO,1994. 12 Royal College of Physicians. Medication for older people. 2nd ed. London: RCP, 1997. 13 Department of Health. Choice and opportunity, Primary Care: The Future. London: HMSO, 1996. 14 Department of Health. Primary Care: Delivering the future. London: HMSO, 1996. 15 Pharmacy Practice Research Resource Centre. Pharmacy Practice Research Directory: Health Authorities. Manchester: PPRRC, University of Manchester, 1996. 16 Hanlon JT, Weinberger M, Samsa GP, Schmader KE, Uttech KM, Lewis IK, Cowper PA, Laindsman PB, Cohen HJ, Feusorer JR. A randomised, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy. Am J Med 1996;100:428-37. 17 Cassidy IB et al. Impact of pharmacist-operated general medicine chronic care refill clinics on practitioner time and quality of care. Ann Pharmacother 1996;30:745-51.

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18 Borgsdorf LR, Miano JS, Knapp P R. Pharmacist-managed medication review in a managed care system. Am J Hosp Pharm 1994;51:772-7. 19 Deady JE et al. Measuring the ability of clinical pharmacists to effect drug therapy changes in a family practice clinic using prognostic indicators. Hosp Pharm 1991;26:93-7. 20 Lobas NH et al. Effects of pharmaceutical care on medication cost and quality of patient care in an ambulatory-care clinic. Am J Hosp Pharm 1992;49:1681-8. 21 Cantril JA, Bueton S,Sibbald B. Indicators of the appropriateness of long term prescribing in general practice in the United Kingdoms’ Consensus development, face & content validity, feasibility and reliability. Q Health Care 1998;7:1305. 22 Burtonwood AM, Hinchliffe AL, Tinkler GS. A prescription for quality: a role for the clinical pharmacist in general practice. Pharm J 1998;261:678-80. 23 Goldstein R, Hulme H, Willits J. Reviewing repeat prescribing – general practitioners and community pharmacists working together. Int J Pharm Pract 1998;6:60-6. 24 Sykes D, Westwood P, Gilleghan J. Development of a review programme for repeat prescription medicines. Pharm J 1996;256:458-60. 25 Granas AG, Bates I. The effect of pharmaceutical review of repeat prescriptions in general practice. Int J Pharm Pract 1999;7:264-75. 26 Lowe CJ, Raynor DK, Courtney EA, Purvis J. Effects of selfmedication programme on knowledge of drugs & compliance with treatment in elderly patients. Br Med J 1995;310:1229-31. 27 Lowe CJ, Raynor DK, Purvis J, Farrin AJ, Hudson J. Effects of a medicine review and education programme in an elderly general practice population. BR J Clin Pharm 2000; In Press. 28 Department of Health. Review of prescribing, supply and administration of medicines, London: HMSO; 1999.